Cryolife Inc CryoValve, Pulmonary Valve and Conduit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Pulmonary Valve and Conduit
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor Number: 70022, Serial Number: 8056613, Model Number: PV00
Products Sold
Donor Number: 70022, Serial Number: 8056613, Model Number: PV00
Cryolife Inc is recalling CryoValve, Pulmonary Valve and Conduit due to During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detecte. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
Recommended Action
Per FDA guidance
Consignee was notified by letter on 01/12/2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
KS
Page updated: Jan 10, 2026